Multi-Center Pilot Study of truSculpt Device

This is an Exploratory Multi-center, Pilot Study to Evaluate the Safety, Efficacy and Ergonomics of Cutera truSculpt Device. Subjects May Receive up to Three Treatments and Will be Followed at 12 Weeks Post the First and Final Treatment.

An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

Study Overview

• Status: Completed
• Conditions: Body Fat; Bulging
• Intervention / Treatment: Device: truSculpt

Detailed Description

This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Associates of South Florida
  • Illinois
    • Naperville, Illinois, United States, 60563
      • The Dermatology Institute of DuPage Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, 18 to 65 years of age (inclusive).
3. Subject has visible fat bulges in the area to be treated.
4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
6. Subject must adhere to the follow-up schedule and study instructions.
7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
5. Has metal implant(s) within the body, such as artificial heart valves.
6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
7. History of any disease or condition that could impair wound healing.
8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: truSculpt; truSculpt treatment	Device: truSculpt; Subjects will receive utreatments and will be followed at 12 weeks post final treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Fat Assessment by Investigator	Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes	12 weeks post final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric Comparison of Circumferential measurement in cm	Difference in circumferential measurement in cm from baseline and at 12 weeks post first and final treatments.	Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Ultrasound Comparison of Subcutaneous fat measurements	Difference in Subcutaneous fat measurement from baseline and at 12 weeks post first and final treatment.	Comparison of baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Temporal Photo Identification	Correct identification of the 12 weeks post first and final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the subjects.	Comparison of Baseline to 12 weeks post first treatment, and to 12 weeks post final treatment
Body Fat Assessment by blinded reviewer	Blinded improvement assessments of body fat as assessed by blinded reviewers using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement (76 - 100%), +3=Significant Improvement(51 - 75%), +2=Moderate Improvement (26 - 50%), +1=Mild Improvement (6 - 25%), and 0=No Change (0 - 5%) at 12 weeks post the first and final treatments	At 12 weeks post first treatment and at 12 weeks post final treatment
Body Fat Assessment by Investigator	Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement (76 - 100%), +3=Significant Improvement(51 - 75%), +2=Moderate Improvement (26 - 50%), +1=Mild Improvement (6 - 25%), and 0=No Change (0 - 5%)	At 12 weeks post first treatment and at 12 weeks post final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Ashish Bhatia, MD, The Dermatology Institute of DuPage Medical Group; Principal Investigator: Joely Kaufman, MD, FAAD, Skin Associates of South Florida; Principal Investigator: Stephen Ronan, MD, Cutera Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 7, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-17-TS16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes